Efficacy of Manual Therapy and Sacroiliac Joint Injection in Sacroiliac Joint Dysfunction

Sponsor

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05181579

Collaborator

(none)

Enrollment

Location

Arms

11.1

Anticipated Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the efficacy of manual therapy and sacroiliac joint injections in patients with sacroiliac joint dysfunction

Condition or Disease	Intervention/Treatment	Phase
Sacroiliac Joint Somatic Dysfunction	Other: Manuel therapy Other: Sacroiliac joint injection	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

34 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Efficacy of Manual Therapy and Sacroiliac Joint Injection in the Treatment of Patients With Sacroiliac Joint Dysfunction

Actual Study Start Date :

Sep 29, 2021

Anticipated Primary Completion Date :

Mar 1, 2022

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Manuel therapy and exercise group Patients in the manual therapy group will receive 3 to 5 sessions of sacroiliac joint manipulation once a week, depending on the treatment response. And home exercises will be given and told. Each patient will do exercise 4 days a week for 4 weeks.	Other: Manuel therapy Some sacroiliac manipulation and mobilization techniques will be applied to patients by an experienced physiatrist. Patients in the manual therapy group will receive 3 to 5 sessions of sacroiliac joint manipulation once a week, depending on the treatment response
Experimental: Sacroiliac injection and exercise group To patients in the injection group corticosteroid (1 ml 40 mg methylprednisolone) and local anesthetic (1 ml 1% lidocaine)will be injected into the sacroiliac joint using a 22 G spinal needle, guided by fluoroscopy (C-arm fluoroscopy). And home exercises will be given and told. Each patient will do exercise 4 days a week for 4 weeks.	Other: Sacroiliac joint injection Corticosteroid (1 ml 40 mg methylprednisolone) and local anesthetic (1 ml 1% lidocaine) will be injected into the sacroiliac joint using a 22 G spinal needle, guided by fluoroscopy (C-arm fluoroscopy) by an experienced physiatrist. It will be applied just one time.

Arm

Intervention/Treatment

Experimental: Manuel therapy and exercise group

Patients in the manual therapy group will receive 3 to 5 sessions of sacroiliac joint manipulation once a week, depending on the treatment response. And home exercises will be given and told. Each patient will do exercise 4 days a week for 4 weeks.

Other: Manuel therapy

Some sacroiliac manipulation and mobilization techniques will be applied to patients by an experienced physiatrist. Patients in the manual therapy group will receive 3 to 5 sessions of sacroiliac joint manipulation once a week, depending on the treatment response

Experimental: Sacroiliac injection and exercise group

To patients in the injection group corticosteroid (1 ml 40 mg methylprednisolone) and local anesthetic (1 ml 1% lidocaine)will be injected into the sacroiliac joint using a 22 G spinal needle, guided by fluoroscopy (C-arm fluoroscopy). And home exercises will be given and told. Each patient will do exercise 4 days a week for 4 weeks.

Other: Sacroiliac joint injection

Corticosteroid (1 ml 40 mg methylprednisolone) and local anesthetic (1 ml 1% lidocaine) will be injected into the sacroiliac joint using a 22 G spinal needle, guided by fluoroscopy (C-arm fluoroscopy) by an experienced physiatrist. It will be applied just one time.

Outcome Measures

Primary Outcome Measures

Numeric Rating Scale, NRS [Change from baseline NRS at 3 months]
NRS is an 11-grade scale that evaluates the severity of pain in adults .NRS is one of the most commonly used scales in the assessment of pain severity. Possible scores ranges from 0( no pain) to 10 ( worst pain)

Secondary Outcome Measures

Oswestry Disability index [Baseline, Month 1, Month 3, Month 6]
The Oswestry disability index will be used to evaluate how much the patients' low back pain limits their activities in daily life. This index was first created in 1980 . The questionnaire consists of 10 sections, each assessing limitations in different daily activities and functions. Each section is scored from 0 to 5. A score of 0 indicates that there is no restriction while doing that activity, while a score of 5 represents the highest level of restriction in that activity. The maximum score is 50. As the total score increases, the disability level of the individual increases. In 2004, Turkish validity study was carried out by Yakut et al.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Low back and/or gluteal pain and/or groin pain without radicular extension below the L4 level for more than 3 months
Pain score greater than 3 according to NRS
Unresponsiveness to conservative treatment (such as exercise, NSAID)
At least 3 of the five sacroiliac provocation tests (FABER (Patrick), thigh thrust, Gaenslen, sacroiliac compression, and sacroiliac distraction tests) are positive

Exclusion Criteria:

Refusing to participate in the study
Pregnancy
History of inflammatory disease (ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, etc.)
Infective sacroiliitis
Malignancy
Osteoporosis
Mechanical lumbosacral pathologies (spondylolisthesis, scoliosis, stenosis, etc.)
Neurological finding in the lower extremity
Pain spreading below the knee
History of spinal surgery
History of allergy to drugs to be injected (local anesthetic, contrast material, steroid allergy)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	SBU,Gaziler Physical Medicine and Rehabilitation Education and Research Hospital	Ankara	Cankaya	Turkey	06800

Sponsors and Collaborators

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Investigators

Study Director: Umut Guzelkucuk, MD, SBU,Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yasin Demir, Associate professor, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

ClinicalTrials.gov Identifier:

NCT05181579

Other Study ID Numbers:

First Posted:

Jan 6, 2022

Last Update Posted:

Jan 6, 2022

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Yasin Demir, Associate professor, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Sacroiliac joint dysfunction

Manuel therapy

Sacroiliac joint injection

Additional relevant MeSH terms:

Joint Diseases

Study Results

No Results Posted as of Jan 6, 2022